Whitehawk Therapeutics, Inc. Q4 FY2022 earnings call

• Commercial Launch: Successfully launched FYARRO for advanced malignant PEComa in 2022. It was added to NCCN Clinical Practice Guidelines and received a permanent J code, facilitating payer coverage. Achieved $15.2M in sales in 2022, outperforming estimates in just 10 months on the market.
• Clinical Trials: Initiated Phase 2 PRECISION 1 trial in patients with solid tumors with TSC1 or TSC2 inactivating alterations; expect preliminary data in Q2 2023. Collaborated with Mirati Therapeutics for a combination clinical study in patients with KRAS G12C mutations.
• Financing: Completed a $72.5M pipe financing, extending runway into 2025 and supporting operations.
• Adoption: FYARRO had $5.2M in Q4 sales, 23% growth over Q3; ~half of business from community clinics/hospitals; over 120 unique ordering accounts, up 34% from prior quarter, reorder rate >85%.
• Board Addition: Added Dr. Mohammad Hirmand to the Board, bringing clinical development and operational expertise.

The key product segment is FYARRO. In the fourth quarter of 2022, FYARRO sales amounted to $5.2 million, which is a 23% growth compared to Q3. For the full year 2022, FYARRO achieved sales of $15.2 million. There is no specific revenue contribution percentage provided for FYARRO relative to the company's total revenue.

• Expect preliminary data from PRECISION 1 trial in the second quarter of 2023.
• Mirati will dose the first patient in their combination trial with adagrasib and nab-sirolimus in KRAS G12C mutants during the second quarter of 2023.

• Staffing shortages due to COVID pandemic impact are affecting trial recruitment for PRECISION 1.
• Uncertainties in clinical trial timelines and outcomes, such as with PRECISION 1 enrollment and the Mirati collaboration trial.
• Dependence on regulatory approvals and payer coverage for continued adoption and sales of FYARRO.

Q: Could you provide anecdotal comments on patient characteristics of FYARRO treatment, line of therapy, duration on treatment, and future sales guidance?

A: Early on, patients were in progress with therapy; moving closer to first line, but still early with 10 months on the market, so still a ways from guidance but happy with progress.

Q: What would be considered a meaningful end for PRECISION 1 preliminary readout and where will the data be reported?

A: Meaningful end is double digits in patients; data will be released via company press release or event, not at a scientific meeting.

Q: Questions on FYARRO revenues, TSC1/TSC2 in endometrial cancers, and expanded access program (EAP)?

A: On revenues, north of 85% of commercial lives covered; TSC1/TSC2 alterations in ~3-4% of endometrial cancers, sub-analysis of AMPECT study showed 43% response in PEComas from endometrial cancer; EAP data from ASCO 2021 had endometrial cancer patients responding well with long duration.

Q: Questions on PRECISION 1 recruitment difficulties and Mirati collaboration data expectations?

A: PRECISION 1 still expects to complete enrollment in spring 2024 despite COVID staffing issues; Mirati trial is a Phase 1 where dose needs to be worked out, no results expected this year but possible next year.